1. Technical Field
This disclosure relates generally to an electrosurgical device of the type having an actuator for alternating between a cauterizing and a cutting mode. More particularly, the present disclosure relates to an electrosurgical device having an elastomeric seal for providing bio-contamination and dielectric protection by preventing fluids from entering the nose and actuator areas of the electrosurgical device.
2. Background of the Related Art
Electrosurgical devices suitable for use in surgical procedures such as cauterizing, cutting and similar procedures are well known. For example, U.S. Pat. Nos. 3,648,001; 3,801,766; 4,827,911; 4,827,927; 5,088,997; 5,217,457; and 5,244,462, the contents of which are incorporated herein by reference, disclose such electrosurgical devices. Typically, these electrosurgical devices introduce RF cauterizing current, cutting current, or a blend thereof to a conductive blade inserted within a nose area of a longitudinal housing by means of a finger-operated switch actuating member disposed on the housing and electrically coupled to the electrode and a generator. Optionally, such devices include suction and irrigation capabilities. These features are typically controlled through control mechanisms contained within the electrosurgical device and are actuated with the actuating member or some other actuator disposed on the housing or on the generator.
In some procedures, the advancement of the blade into body tissue to perform a surgical procedure causes fluids and bio-materials to collect near the device adjacent the nose or actuator areas. These fluids and bio-materials may deposit on the control mechanisms and wires within the housing thereby making it difficult to sterilize and reuse the device. Additionally, conductive fluids can provide an undersirable conductive path from the electrode to the surgeon and other objects in the surgical site, if fluid enters the nose or actuator areas.
Accordingly, a need exists for an electrosurgical device where the main operating components and mechanisms are provided within a sealed environment to provide bio-contamination and dielectric protection. A need further exists for a method of manufacturing an electrosurgical device where the method provides at least one seal for the electrosurgical device. Another need which exists is for an electrosurgical device having a counting mechanism for indicating to an operator the number of times the device has been plugged into an electric generator. Still, a need exists for the counting mechanism to have a disable mechanism for preventing the electrosurgical device from being plugged into the electric generator after a pre-determined amount of insertion and removal operations. A need also exists for a seal that can be easily applied to an electrosurgical device, is inexpensive, simple and reliable and which provides bio-contamination and dielectric protection by inhibiting the ingress of fluids and contaminants through the nose and actuator areas. A need further exists for a seal that provides bio-contamination and dielectric protection by inhibiting the ingress of fluids and contaminants through the nose and actuator areas.
In accordance with the present disclosure, an electrosurgical device is provided having at least one elastomeric seal capable of providing bio-contamination and dielectric protection by inhibiting the ingress of fluids and contaminants through the nose and actuator areas. The electrosurgical device is of the type used to perform cauterizing and cutting of body tissue by means of a finger-actuated switch actuating means. The elastomeric seal is manufactured from a thermoplastic elastomer or resin which is placed in liquid form within a mold. A housing partial-section having the main circuit components and mechanisms of the electrosurgical device is then placed within the mold. Once the elastomer cures, the elastomeric seal seals the components and mechanisms within the housing partial-section. The elastomeric seal defines a flexible first opening at a distal end of the electrosurgical device to accommodate varying diameters of electrodes or blades connected to the nose area of the electrosurgical device.
An actuator seal is also provided on the actuator area of the electrosurgical device to prevent fluids and contaminants from entering the electrosurgical device through the actuator area. Two buttons are insert molded within the actuator seal and are operatively associated with a self-cleaning switching mechanism within the housing partial-section to operate the electrosurgical device between a cutting and coagulating mode. The actuator seal is also manufactured from a thermoplastic elastomer or resin.
The preferred self-cleaning switching mechanism includes a switch contact plate having pair of movable contacts with contact faces. Each movable contact corresponds to a stationary contact positioned within a circuit mold. Each stationary contact has a contact face aligned with a respective contact face of the corresponding movable contact. As the actuator seal is depressed, contact faces of the movable and stationary contacts slide along each other to clean the contacts of, e.g., non-conductive corrosion and contaminants.
The electrosurgical device is further provided with a counting mechanism for counting the number of times the device is plugged into an electric generator. The counting mechanism is included at the proximal end of an electrical cord electrically connecting circuitry within the electrosurgical device and the electric generator.
Further, in accordance with the present disclosure, an elastomeric seal is disclosed which is manufactured separately from an electrosurgical device it is intended to seal. The seal defines a first opening at a distal end and a second opening at a proximal end for fitting the elastomeric seal over the electrosurgical device. An actuating member pocket is defined in proximity to the second opening for fitting the actuating member therein. The seal further includes a lip portion having an elastic wall circumferentially surrounding the first opening to accommodate varying diameters of electrodes.
In an alternate embodiment, an elastomeric seal is chemically adhered, if the seal is desired to be reusable, or mechanically attached, if the seal is desired to be disposable, to the nose area of an electrosurgical device to prevent fluids and bio-materials from entering the nose area and preventing establishment of a conductive path. It is contemplated that the seal can be friction fit to the nose area of the electrosurgical device as well. Preferably, the elastomeric seal includes a soft lip to permit electrodes and blades of varying diameters to be inserted and sealed.